US biopharma company Incyte bags Opzelura FDA approval for vitiligo
Opzelura FDA approval for vitiligo : Incyte has secured approval for Opzelura (ruxolitinib) cream 1.5% from the US Food and Drug Administration (FDA) for the topical treatment of nonsegmental vitiligo in adult and pediatric patients, aged 12 and older.
Opzelura is a cream formulation of ruxolitinib, which selectively inhibits JAK1/JAK2.
Opzelura FDA approval for vitiligo was driven by the findings of phase 3 TRuE-V clinical trial program, which assessed the safety and efficacy of the Incyte JAK1/JAK2 inhibitor compared to vehicle in over 600 people having nonsegmental vitiligo, aged 12 and older. The vehicle in this case was a non-medicated cream.
In the late-stage studies, treatment with Opzelura led to considerable improvements in VASI scores, which represent improvements in repigmentation of facial and total body at Week 24, compared to vehicle and in an open-label extension at Week 52.
Hervé Hoppenot — Incyte CEO, commenting on Opzelura FDA approval for vitiligo, said: “With the approval of Opzelura in nonsegmental vitiligo, Incyte has once again delivered a treatment to patients with high unmet medical need who previously had no approved therapies.
“We are proud of Incyte’s scientists and development teams that have made this milestone possible, and we’re pleased that eligible vitiligo patients now have a choice to address repigmentation.”
Last September, Opzelura was given FDA approval for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in patients who are not immunocompromised.